SUPPLY CHAIN ARTICLES
-
![iStock-1095134748]( "Therapeutic Oligonucleotides: Regulations & Quality Standards")
Therapeutic Oligonucleotides: Regulations & Quality StandardsOligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
-
![Teamwok-GettyImages-1411776159]( "4 Risk Mitigation Strategies For mRNA Production")
4 Risk Mitigation Strategies For mRNA ProductionPlanning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
-
![Business Unity-GettyImages-1253212054]( "The RNA Therapeutics Supply Chain: A Platform of Relationships")
The RNA Therapeutics Supply Chain: A Platform of RelationshipsConversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
-
![women gossiping-GettyImages-72131155]( "A \"Hot Take\" on Personalized mRNA Medicines")
A "Hot Take" on Personalized mRNA MedicinesmRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
-
![Cell transfection with plasmid GettyImages-1290924802]( "Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why")
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's WhyThe demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
-
![Talimogene laherparepvec vaccine-GettyImages-960686030]( "Addressing Challenges In Serialization For Complex Therapeutics")
Addressing Challenges In Serialization For Complex TherapeuticsThe magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
SUPPLY CHAIN VIDEOS
What challenges do you consider the most formidable in your own mRNA therapeutic development environments?
Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.
Looking to enhance performance and manufacturing from your DNA backbone without the regulatory concerns? Gain advantages over legacy plasmid DNA backbones and minicircles.
In this Advancing RNA Live clip, Sail Biomedicines’ Marc Wolfgang gives us a brief primer on the main differences and challenges in developing an IVT reaction for circular RNA, as opposed to linear mRNA.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![iStock-1087219198-lab-computer-cleanroom-research-development-production]( "GMP-Source® And Phase-Appropriate Use For Early-Stage Clinical Trials")
GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.
-
![Synthego sgrna bucket]( "CRISPR sgRNA For Successful Gene Editing: Discovery To Clinic")
The single guide RNA (sgRNA) is one of the key components of successful CRISPR gene editing. Here we cover all the important aspects of sgRNA and Synthego’s sgRNA products.
-
![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
-
![Gene Therapy iStock-1291142726]( "Key Challenges for CRISPR In Clinical Development")
Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
-
![DNA strands, genetic biotechnology, gene cell-GettyImages-2154784301]( "Reduce Contamination Risks When Storing Synthetic DNA")
An alternative to traditional polyethylene bags is offering cell and gene therapy manufacturers a solution to contamination concerns regarding DNA or RNA fragments.
-
![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
-
![GettyImages-1284041821 asian vaccine]( "Revolutionizing Patient-Centric Supply Chains To Improve Vaccine Access")
Transparent collaboration and innovation are essential to establishing an infrastructure that supports more agile business models and empowers widespread vaccine access.
